Utility of Exparel Based ESP Blocks in Elective Posterior Spine Fusion

Anesthesia, Local Clinical Trial

Official title:

Utility of Exparel Based Erector Spinae Plane Block for Elective 1 and 2 Level Posterior-based Lumbar Fusion: A Randomized Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06107660
• Other study ID #: HHC-2023-0204
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 2023
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: Hartford Hospital
• Contact: Heeren Makanji, MD
• Phone: 860-549-8252
• Email: Heeren.Makanji[@]hhchealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare two different medications used to reduce pain during lower back fusion surgery. The main questions this study aims to answer are: 1. Can liposomal bupivacaine, when included in a regional anesthesia technique called the Erector Spinae Plane block (ESPB), reduce opioid use post-operatively compared to the standard medication typically used in an ESPB (bupivacaine with stabilizing agents)? 2. Do patients report lower pain and better satisfaction with their surgery when they receive liposomal bupivacaine in the ESPB compared to those that receive the standard medication? Participants will be randomized to into two groups one that receives liposomal bupivacaine and one group that receives bupivacaine with stabilizing agents. Other than the randomization all patients will follow current standard of care at our hospital, and will not be asked to complete any additional study forms in addition to forms currently asked of all patients as per standard of care.

Description:

The purpose of this study is to improve pain management for patients having spine fusion surgery. This aim will be achieved by evaluating how well liposomal bupivacaine (LB), an FDA approved numbing medication that can provide pain relief for up to 72 hours after surgery, works when used as a single dose in a regional block known as Erector Spinae Plane block (ESPB). ESPB is a regional anesthesia technique used to control pain after surgery by injecting numbing medication around the patient's back bones on both sides. The study will compare how well LB in ESPB works compared to the standard practice procedure, which involves administering the traditional numbing medication (bupivacaine) through the ESPB. These two medications will be evaluated in reducing postoperative opioid medication need to control postoperative pain, as the primary goal. This study seeks to understand whether an ESP block either with bupivacaine and stabilizing agents or using liposomal bupivacaine, reduces the total amount of opioid medication used postoperatively, reduces pain scores, and leads to better patient reported outcome scores, patient satisfaction, and reduced recovery time in the PACU. Should the investigator find that liposomal bupivacaine is not superior to bupivacaine with stabilizing agents, this information would prove useful in regards to analgesic options for this patient population and could lead to a substantial cost savings.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• Lumbar pathology requiring a single or two level elective posterior based (i.e. posterior or transforaminal approach) spine fusion with or without an interbody device.
• Surgical approach through either a midline or paramedian incision
• Primary fusion surgery, previous decompression surgery is acceptable
• American Society of Anesthesiologists (ASA) score of 1,2,or 3.

Exclusion Criteria:

• Patients currently on narcotic pain medication for pain management
• Patients with a history of illicit drug use
• Patients with neuromuscular disorders or neurological deficits (i.e. post polio or myasthenia gravis)
• Patients confined to a wheelchair for over 6 months
• Patients with fibromyalgia or other chronic pain disorder
• Patient with contraindications for use of the ESP block (i.e. local skin infection over the area of needle entry, or anaphylactic reaction to bupivacaine)
• Non-invasive surgical approaches
• Repeat or revision surgery
• Non-posterior spine surgical approaches (i.e. lateral, oblique, anterior, anterior and posterior approaches)
• Staged procedures
• Adjacent segment surgery
• Patients with a weight less than 40kg to avoid local anesthetic systematic toxicity.

Related Conditions & MeSH terms

• Anesthesia, Local
• Spine Fusion

Intervention

Drug:
• Liposomal bupivacaine
Patients will receive either liposomal bupivacaine as part of the ESPB .
• Bupivacaine
This is the control group comparator as this is standard of care at the investigator's institution.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hartford Hospital

References & Publications (1)

Makanji HS, Solomito MJ, Maffeo-Mitchell C, Esmende S, Finkel K. Utility of Erector Spinae Plane Blocks for Postoperative Pain Management and Opioid Reduction Following Lumbar Fusions. Clin Spine Surg. 2023 May 1;36(4):E131-E134. doi: 10.1097/BSD.0000000000001387. Epub 2022 Sep 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid Use	Opioid Use in patient stay measured in morphine milligram equivalents	72 hours (standard inpatient stay)
Secondary	Pain Report at Rest-Immediate postop	Pain as measured using Numeric Pain Scale (NPS) while patient is at rest immediate postoperative. The minimum value on the NPS is 0 indicating no pain (best outcome) and 10 indicates severe pain (worst outcome)	Asked immediately after surgery while patient is recovering in the post-anesthesia care unit (PACU).
Secondary	Pain Report with activity-Immediate postop	Pain as measured using Numeric Pain Scale (NPS) while patient is active immediate postoperative. The minimum value on the NPS is 0 indicating no pain (best outcome) and 10 indicates severe pain (worst outcome)	Patient is asked their pain level once they have been moved to their hospital room from the PACU. Typically this occurs within 5 hours of surgery.
Secondary	Pain Report at Rest-Post op day 1	Pain as measured using Numeric Pain Scale (NPS) while patient is at rest 24 hours after surgery. The minimum value on the NPS is 0 indicating no pain (best outcome) and 10 indicates severe pain (worst outcome).	24 hours post-op
Secondary	Pain Report with activity-Post op day 1	Pain as measured using Numeric Pain Scale (NPS) with activity 24 hours after surgery. The minimum value on the NPS is 0 indicating no pain (best outcome) and 10 indicates severe pain (worst outcome).	24 hours post-op
Secondary	Pain Report at rest-at discharge	Pain as measured using Numeric Pain Scale (NPS) while patient is at rest at discharge. The minimum value on the NPS is 0 indicating no pain (best outcome) and 10 indicates severe pain (worst outcome).	72 hours post-op
Secondary	Pain Report with activity-at discharge	Pain as measured using Numeric Pain Scale (NPS) with activity at discharge. The minimum value on the NPS is 0 indicating no pain (best outcome) and 10 indicates severe pain (worst outcome).	72 hours post-op
Secondary	PACU recovery time	Time from entry into PACU to time patient is listed as recovered	<5 hours post op
Secondary	Patient Statisfcation	Based on Press Ganey Patient Satisfaction Survey. The minimum score is 0 (very poor) while the maximum score is 100 (very good).	10-14 days post-op
Secondary	Patient reported outcomes score	Oswestry Disability Index (ODI) score. The minimum ODI score is 0 and represents minimal disability, while the maximum score of 100 represents the worst outcome - bed-bound significant disability.	3 months post-op